Below is a brief update on several Rx-360 Working Groups:
The Audit Operations Group. Clare Gosling of AstraZeneca and Darcy Ewalt of Merck & Co are Co-Chairs of the Group. The Group has helped to implement the on-going Rx-360 Audit Program Training Courses, two of which were held in May and two in June. These courses will be held quarterly thereafter. The purpose of the courses is to help organizations educate personnel on how the audit programs work, and what they can do to enhance the processes. The Audit Operations Group is developing other initiatives to continue advancement of the audit programs including a Top 100 supplier site effort to enhance the number of audits scheduled. The Group continues to review progress of the database, audit programs, and new audit firms and auditors, and consider potential new guidelines for use.
The Audit Database Subgroup is transitioning from evaluation of database vendors to implementation of the Board’s chosen solution. A plan with key dates and milestones is under preparation. The project kick-off is expected to begin later in July and to continue through the rest of the year. The Working Group will conduct a risk assessment and create a validation plan for the new database.
The Monitoring and Reporting Working Group continues to promote rapid sharing of important regulatory, legislative and policy developments relevant to supply chain integrity and pharmaceutical quality by preparing timely summary analyses which are publicly available on the Rx-360 website. The Working Group also periodically prepares brief, high-level updates on regulatory updates of interest to Rx-360 community, but not directly related to supply chain issues. The Group has posted 20 summaries thus far during 2012 and they continue to serve as an important resource.
The External Relations/Regulatory Affairs Working Group continues to provide regular updates to the pharmaceutical, supply chain and regulatory communities with information on Rx-360’s activities. Rx-360 continues to attract new members. The Working Group is organizing presentations/ booths at several upcoming conferences. Rx-360 is planning an event at CPhI (9-11 October 2012, Madrid, Spain). Rx-360 will also be present at FDA/PDA Pharmaceutical Supply Chain Conference (13-14 November 2012, Rockville, MD). The Working Group also engages regulators around the world in order to facilitate constructive relationships and keep them informed of Rx-360’s activities. The Working Group, in coordination with the Board, works to ensure that Rx-360’s initiatives are aligned with regulators’ expectations and priorities and are keen to solicit and respond to feedback world in order to facilitate constructive relationships and keep them informed of Rx-360’s activities. The Working Group, in coordination with the Board, works to ensure that Rx-360’s initiatives are aligned with regulators’ expectations and priorities and are keen to solicit and respond to feedback from regulators. Rx-360 has engaged with numerous regulatory representatives, including from PIC/S, US FDA, EMEA, MHRA, and Irish Medicines Board.
The Supply Chain Security Steering Committee’s four working groups on Management Systems (to describe a mature supply chain security system); Audits and Assessments of Third Party Providers; Market Monitoring; and Conveyance Risk Management have completed their deliverables – a series of White Papers and tools – along with presenting public webinars on all of the deliverables at the time of their issuance. These webinars were very well-attended by global representatives from industry and regulatory agencies. The Steering Committee is currently identifying new as well as follow-up topics to address.
Organizations interested in becoming an Rx-360 Member or Observer should contact the Rx-360 Secretariat at [email protected].